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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name meningitis/encephalitis pathogen multiplex nucleic acid detection system
510(k) Number K190219
Device Name Simplexa VZV Direct, Simplexa VZV Positive Control Pack
Applicant
DiaSorin Molecular LLC
11331 Valley View Street
Cypress,  CA  90630
Applicant Contact Sharon Young
Correspondent
DiaSorin Molecular LLC
11331 Valley View Street
Cypress,  CA  90630
Correspondent Contact Sharon Young
Regulation Number866.3970
Classification Product Code
PLO  
Date Received02/04/2019
Decision Date 05/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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